Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K103842 |
Device Name |
UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 |
Applicant |
BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD |
MAIL STOP E2 SE08 |
BREA,
CA
92821
|
|
Applicant Contact |
MARINE BOYAJIAN |
Correspondent |
BECKMAN COULTER, INC. |
250 S. KRAEMER BOULEVARD |
MAIL STOP E2 SE08 |
BREA,
CA
92821
|
|
Correspondent Contact |
MARINE BOYAJIAN |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/30/2010 |
Decision Date | 04/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|